Innovating Shorter, All- Oral, Precised Treatment Regimen for Rifampicin Resistant Tuberculosis:BDLL Chinese Cohort
China120 participantsStarted 2024-11-27
Plain-language summary
This is an investigational, prospective, multicenter, single-arm, open label trial. The goal of this clinical trial is to evaluate the efficacy and safety of a 6-month all-oral regimen, consisting of Bedaquiline (BDQ, B), Delamanid (DLM, D), Linezolid (LZD, L), Levofloxacin (LFX) or Clofazimine (CFZ, C), or BDLLfxC regimen, to treat rifampin-resistant pulmonary tuberculosis (RR-TB) in Chinese teenagers and adults (aged 12 years or above). The main questions it aims to answer are:
* Is BDLLfxC regimen effective to treat RR-TB in Chinese participants?
* Is BDLLfxC regimen safe in Chinese RR-TB participants? Participants will take BDLLfxC regimen to treat their RR-TB. There will be no additional hospital visits, laboratory tests or radiological examinations other than routine clinical practice.
Who can participate
Age range12 Years
SexALL
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Inclusion Criteria:
* Participants are willing to sign informed consent of this trial, those without capacity for civil conduct need their legal guardian to sign
* Participants (and their legal guardian if applicable) are willing to cooperate to complete all trial procedures
* Male or female, 12 years or older, weight ≥ 30kg
* Confirmed pulmonary tuberculosis with resistance to rifampin by phenotypic or genotypic susceptibility testing within 3 months, and must be re-confirmed by sputum culture sampled at trial inclusion
* Women with childbearing potential should not be pregnant, confirmed by a volunteered negative pregnancy test, and are willing to use effective contraceptive method from giving consent to 3 months after study treatment
* Men with childbearing potential must be willing to use condom or other effective contraceptive methods to avoid their sex partners from being pregnant
* Women in breastfeeding period must be willing to discontinue breastfeeding from giving consent to 3 months after study treatment
* Participants are willing to take HIV test, and willing to take appropriate antiretroviral therapy if positive
Exclusion Criteria:
* Previously use of Bedaquiline or Delamanid for at least 28 days
* Concomitant hematogenous disseminated tuberculosis, or severe pulmonary tuberculosis in investigator's opinion (including tuberculosis of the digestive system, osteoarticular tuberculosis or tuberculous meningitis)
* Currently using any drug that has been prohibited…
What they're measuring
1
Proportion of participants with favorable outcomes in both treatment and follow-up period
Timeframe: Up to 72 weeks after start of treatment